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510(k) Data Aggregation
K Number
K172284Device Name
NAPA LP-15 Airway Pressure Monitor
Manufacturer
DRW Medical, LLC
Date Cleared
2018-02-09
(196 days)
Product Code
CAP
Regulation Number
868.2600Why did this record match?
Applicant Name (Manufacturer) :
DRW Medical, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NAPA LP-15 Airway Pressure Monitor is intended to measure and monitor airway pressure for neonatal patients being treated with positive pressure therapy, including neonatal Continuous Positive Airway Pressure (CPAP) devices (e.g. Bubble CPAP). The device provides audible and visual alarms when the airway pressure falls outside of the user selected high and low alarm limits. The device is intended to be pole mounted for stationary use in hospitals only. For professional use only.
Device Description
The NAPA LP-15 Airway Pressure Monitor is a compact mains operated monitoring device that continuously monitors and displays the neonatal patient's average airway treatment pressure during neonatal CPAP therapy (e.g. Bubble CPAP) and provides high and low alarms for pressures that exceed set limits.
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